Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance)
|23 July 2012
|environnement,sécurité des travailleurs et de la population,Marché intérieur - Principes,medio ambiente,seguridad de los trabajadores y de la población,Mercado interior - Principios,ambiente,sicurezza dei lavoratori e della popolazione,Mercato interno - Principi
|Official Gazette Publication
|Journal officiel de l’Union européenne, L 142, 31 mai 2008,Diario Oficial de la Unión Europea, L 142, 31 de mayo de 2008,Gazzetta ufficiale dell’Unione europea, L 142, 31 maggio 2008
02008R0440 — EN — 18.05.2017 — 007.001
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|►C1 COMMISSION REGULATION (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance) ◄ (OJ L 142 31.5.2008, p. 1)
|COMMISSION REGULATION (EC) No 761/2009 of 23 July 2009
|COMMISSION REGULATION (EU) No 1152/2010 of 8 December 2010
|COMMISSION REGULATION (EU) No 640/2012 of 6 July 2012
|COMMISSION REGULATION (EU) No 260/2014 of 24 January 2014
|COMMISSION REGULATION (EU) No 900/2014 of 15 July 2014
|COMMISSION REGULATION (EU) 2016/266 of 7 December 2015
|COMMISSION REGULATION (EU) 2017/735 of 14 February 2017
|Corrigendum, OJ L 143, 3.6.2008, p. 55 (440/2008)
COMMISSION REGULATION (EC) No 440/2008
of 30 May 2008
laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
(Text with EEA relevance)
The test methods to be applied for the purposes of Regulation 1907/2006/EC are set out in the Annex to this Regulation.
The Commission shall review, where appropriate, the test methods contained in this Regulation with a view to replacing, reducing or refining testing on vertebrate animals.
All references to Annex V to Directive 67/548/EEC shall be construed as references to this Regulation.
This Regulation shall enter into force on the day following its publication in the Official Journal of the European Union.
It shall apply from 1 June 2008.
Before using any of the following test methods to test a multi-constituent substance (MCS), a substance of unknown or variable composition, complex reaction product or biological material (UVCB), or a mixture and where its applicability for the testing of MCS, UVCB, or mixtures is not indicated in the respective test method, it should be considered whether the method is adequate for the intended regulatory purpose.
If the test method is used for the testing of a MCS, UVCB or mixture, sufficient information on its composition should be made available, as far as possible, e.g. by the chemical identity of its constituents, their quantitative occurrence, and relevant properties of the constituents.
PART A: METHODS FOR THE DETERMINATION OF PHYSICO-CHEMICAL PROPERTIES
|TABLE OF CONTENTS
|FLAMMABILITY (CONTACT WITH WATER)
|PYROPHORIC PROPERTIES OF SOLIDS AND LIQUIDS
|AUTO-IGNITION TEMPERATURE (LIQUIDS AND GASES)
|RELATIVE SELF-IGNITION TEMPERATURE FOR SOLIDS
|OXIDISING PROPERTIES (SOLIDS)
|NUMBER — AVERAGE MOLECULAR WEIGHT AND MOLECULAR WEIGHT DISTRIBUTION OF POLYMERS
|LOW MOLECULAR WEIGHT CONTENT OF POLYMERS
|SOLUTION/EXTRACTION BEHAVIOUR OF POLYMERS IN WATER
|OXIDISING PROPERTIES (LIQUIDS)
|LENGTH WEIGHTED GEOMETRIC MEAN DIAMETER OF FIBRES
|PARTITION COEFFICIENT (1-OCTANOL/WATER): SLOW-STIRRING METHOD
|PARTITION COEFFICIENT (N-OCTANOL/WATER), HIGH PERFORMANCELIQUID CHROMATOGRAPHY (HPLC) METHOD
|DISSOCIATION CONSTANTS IN WATER (TITRATION METHOD — SPECTROPHOTOMETRIC METHOD — CONDUCTOMETRIC METHOD)
A.1. MELTING/FREEZING TEMPERATURE
The majority of the methods described are based on the OECD Test Guideline (1). The fundamental principles are given in references (2) and (3).
The methods and devices described are to be applied for the determination of the melting temperature of substances, without any restriction with respect to their degree of purity.
The selection of the method is dependent on the nature of the substance to be tested. In consequence the limiting factor will be according to, whether or not the substance can be pulverised easily, with difficulty, or not at all.
For some substances, the determination of the freezing or solidification temperature is more appropriate and the standards for these determinations have also been included in this method.
Where, due to the particular properties of the substance, none of the above parameters can be conveniently measured, a pour point may be appropriate.
1.2. DEFINITIONS AND UNITS
The melting temperature is defined as the temperature at which the phase transition from solid to liquid state occurs at atmospheric pressure and this temperature ideally corresponds to the freezing temperature.
As the phase transition of many substances takes place over a temperature range, it is often described as the melting range.
Conversion of units (K to oC)
t = T - 273,15
|Celsius temperature, degree Celsius (oC)
|thermodynamic temperature, kelvin (K)
1.3. REFERENCE SUBSTANCES
Reference substances do not need to be employed in all cases when investigating a new substance. They should primarily serve to check the performance of the method from time to time and to allow comparison with results from other methods.
Some calibration substances are listed in the references (4).
1.4. PRINCIPLE OF THE TEST METHOD
The temperature (temperature range) of the phase transition from the solid to the liquid state or from the liquid to the solid state is determined. In practice while heating/cooling a sample of the test substance at atmospheric pressure the temperatures of the initial melting/freezing and the final stage of melting/freezing are determined. Five types of methods are described, namely capillary method, hot stage methods, freezing temperature determinations, methods of thermal analysis, and determination of the pour point (as developed for petroleum oils).
In certain cases, it may be convenient to measure the freezing temperature in place of the melting temperature.
1.4.1. Capillary method
22.214.171.124. Melting temperature devices with liquid bath
A small amount of the finely ground substance is placed in a capillary tube and packed tightly. The tube is heated, together with a thermometer, and the temperature rise is adjusted to less than about 1 K/min during the actual melting. The initial and final melting temperatures are determined.
126.96.36.199. Melting temperature devices with metal block
As described under 188.8.131.52, except that the capillary tube and the thermometer are situated in a heated metal block, and can be observed through holes in the block.
184.108.40.206. Photocell detection
The sample in the capillary tube is heated automatically in a metal cylinder. A beam of light is directed through the substance, by way of a hole in the cylinder, to a precisely calibrated photocell. The optical properties of most substances change from opaque to transparent when they are melting. The intensity of light reaching the photocell increases and sends a stop signal to the digital indicator reading out the temperature of a platinum resistance thermometer located in the heating chamber. This method is not suitable for some highly coloured substances.
1.4.2. Hot stages
220.127.116.11. Kofler hot bar
The Kofler hot bar uses two pieces of metal of different thermal conductivity, heated electrically, with the bar designed so that the temperature gradient is almost linear along its length. The temperature of the hot bar can range from 283 to 573 K with a special temperature-reading device including a runner with a pointer and tab designed for the specific bar. In order to determine a melting temperature, the substance is laid, in a thin layer, directly on the surface of the hot bar. In a few seconds a sharp dividing line between the fluid and solid phase develops. The temperature at the dividing line is read by adjusting the pointer to rest at the line.
18.104.22.168. Melt microscope
Several microscope hot stages are in use for the determination of melting temperatures with very small quantities of material. In most of the hot stages the temperature is measured with a sensitive thermocouple but sometimes mercury thermometers are used. A typical microscope hot stage melting temperature apparatus has a heating chamber which contains a metal plate upon which the sample is placed on a slide. The centre of the metal plate contains a hole permitting the entrance of light from the illuminating mirror of the microscope. When in use, the chamber is closed by a glass plate to exclude air from the sample area.
The heating of the sample is regulated by a rheostat. For very precise measurements on optically anisotropic substances, polarised light may be used.
22.214.171.124. Meniscus method
This method is specifically used for polyamides.
The temperature at which the displacement of a meniscus of...
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